BETAMETHASONE VALERATE

For topical use only. If no improvement is seen after two to four weeks, the diagnosis should be reconsidered and specialist referral may be necessary. Adults, adolescents and the elderly A small quantity of Betamethasone Valerate should be applied to the affected area one to three times daily until improvement occurs.

025% Ointment. In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of Betamethasone Valerate can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response in such lesions; thereafter improvement can usually be maintained by regular application without occlusion.

Paediatric population Betamethasone valerate is contraindicated in children under one year of age. Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults; Courses should be limited to five days.

Occlusion should not be used. Care should be taken when using betamethasone valerate to ensure the amount applied is the minimum that provides therapeutic benefit. Elderly Clinical studies have not identified differences in responses between the elderly and younger patients.

The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Renal / Hepatic Impairment In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

and Section

Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression, with or without clinical features of Cushing's syndrome and reversible hypothalamic-pituitary- adrenal (HPA) axis, can occur even without occlusion.

9 Overdose). g. on intertriginous areas or under occlusive dressings (in infants the nappy may act as an occlusive dressing) • Increasing hydration of the stratum corneum • Use on thin skin areas such as the face • Use on broken skin or other conditions where the skin barrier may be impaired • In comparison with adults, children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects.

This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults. The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids.

This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema. Therefore, treatment courses should be limited to five days and occlusion should not be used. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma and cataract might result from repeated exposure.

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area.

It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected.

Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use.

If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

In infants and children under 12 years of age, courses should be limited to five days and occlusion should not be used. Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin.

If used in psoriasis careful patient supervision is important. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents.

Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease.

Betamethasone valerate should be used with caution in patients with a history of local hypersensitivity to other corticosteroids. Betamethasone Valerate Ointment is usually well tolerated but if signs of hypersensitivity appear, application should stop immediately.

8) may resemble symptoms of the condition under treatment. Exacerbation of symptoms may occur. Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.

There have been a few reports in the literature of the development of cataracts in patients who have been using corticosteroids for prolonged periods of time. Although it is not possible to rule out systemic corticosteroids as a known factor, prescribers should be aware of the possible role of corticosteroids in cataract development.

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

The label will state strong steroid.

Rosacea, acne vulgaris, Pruritus without inflammation, perioral dermatitis and use in widespread plaque psoriasis. g. herpes simplex, chickenpox). Hypersensitivity to any component of the preparation. g. g. impetigo); primary or secondary infections due to yeast; peri- anal and genital pruritus; dermatoses in children under 1 year of age, including dermatitis and napkin eruptions.